University of Colorado | CU Anschutz Medical Campus
Department: Office of Regulatory Compliance – Clinical Research Administration Office
Job Title: Research Facilitator and Trainer
Position #756545 – Requisition #18441
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers
Who We Are:
The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here at http://www.ucdenver.edu/about/WhoWeAre/Documents/CUAnschutz_facts.pdf .
The Clinical Research Administration Office has an opening for a full-time University Staff (unclassified) Research Facilitator and Trainer position.
Jobs in this career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.
Senior Professionals are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field. Work is performed fully independently.
The UCD Clinical Research Support Center (CRSC) is a unit which has been established within the Office of Regulatory Compliance but in partnership with the Colorado Clinical and Translational Science Institute (CCTSI). The mission of the Clinical Research Support Center is to assist investigators in the development, submission and approval of human subject research.
This position provides ongoing support and guidance to researchers and their team with regard to protocol preparation, and submission, training in the Clinical Trials Management System, Oncore. This position will also be the expert and go to person for Children Hospital Colorado (CHCO) and Denver Health and Hospital Authority (DHHA) employees for training and questions that pertain to Oncore.
Examples of Work Performed:
Assist investigators in evaluating and accessing resources necessary to implement their clinical and translational research via the Human Subjects Research Portal (HSR Portal)
Pre-review non-Oncology Investigator Initiated Studies to determine requirement for review by the Scientific Advisory Review Committee (SARC)
Significant participation in preparation of documents for human subject regulatory submissions
Develop and implement processes necessary to ensure timely review and approval of research protocols and streamline the overall clinical and translational research enterprise timeline.
HSR Portal Duties
Oversee the review and triage HSR Portal submissions for accuracy, completeness, consistency, and required ancillary approvals
Advise study teams on any needed corrections or additions for submissions
Build protocol shells in OnCore for all new portal submissions
Assess HSR portal submissions for accurate development and dissemination of task lists in OnCore
Complete other duties as assigned
Provide feedback, trouble-shoot and propose improvements for efficiency and clarity
Maintain and assist in the development of Standard Operating Procedures relative to the HSR Portal
Provide insight into enhancements and improvements to processes, communication as needed
Conduct OnCore Training on Subject/Protocol
Identify additional training and guidance needs for HSR Portal
Provide guidance and troubleshooting support for study teams
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.
Salary and Benefits:
The starting salary range is $51,000 - $55,000 and commensurate with skills and experience
This position is not eligible for overtime compensation
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Here is a link to an overview of the benefits package at https://www.cu.edu/employee-services/benefits
Here is a link to a Total Compensation Calculator at http://www.cu.edu/node/153125
Diversity and Equity:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at email@example.com
The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution
At least two (2) years of professional level experience in a clinical research setting
Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis
Conditions of Employment:
Experience with working in a clinical trials management system
Experience developing and creating surveys and other tools in RedCap
Experienced in conducting training to adult learners
Experience working with regulatory processes as related to clinical trials is required
Ability to communicate effectively, both in writing and orally
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
Outstanding customer service skills
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Ability to develop and implement processes
Familiarity with FDA and OHRP regulations, ICH GCP guidelines, IRB Policy and Procedures and sponsor operating procedures
Working knowledge and experience in a clinical research setting with adult and pediatric populations
Ability to work in a clinical research setting, both independently and within a team to foster good team working skills between CTRCs, Clinical Research Support Center, COMIRB, research teams, departments, affiliates, and staff
Ability to maintain effective communication with all investigators, study team members, CTRCs, IRB, faculty, and staff
Effectively communicate information through department meetings, one-on-one meetings, general correspondence, training and regular interpersonal communication
Strong interpersonal and communication skills is required
Well-developed oral and written communication skills
Flexibility and the ability to adapt to various situations and environments
Must be detailed oriented
Strong organizational skills able to organize, plan, prioritize, and adjust work assignments while meeting deadlines efficiently with minimal supervision
Strong computer skills. Proficient in Windows, MS Word, Excel, SharePoint
Knowledge of research protocol application processes
Ability to conduct training to adult learners; comfortable communicating with a broad range of trainees and experienced research investigators
Critical thinking skills
Job: Research Services
Primary Location: Aurora
Job Category Research Services
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Aug 18, 2020
Unposting Date Ongoing
Posting Contact Name Deborah Barnard
Posting Contact Email Deborah.Barnard@cuanschutz.edu
Posting Number 00756545
Req ID: 18441
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.
College / University
$1B to 2B
Aurora, CO, and others
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